Safety alerts for human medical products dialysate concentrates used in hemodialysis safety communication - alkali dosing errors highlighted
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This document summarizes a safety communication from the FDA regarding potential alkali dosing errors during hemodialysis treatment. The FDA issued a recall for certain dialysate concentrates that contain acetic acid or acetate, which can contribute to elevated bicarbonate levels and metabolic alkalosis in patients. Healthcare providers are advised to review the components of dialysate concentrates and be aware that metabolic alkalosis increases the risk of adverse health issues like cardiopulmonary arrest. Patients and providers are encouraged to report any adverse events to the FDA.
![7/16/13 Safety Alerts for Human Medical Products > Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm 1/2
Dialysate Concentrates Used in Hemodialysis: Safety Communication -足 Alkali Dosing Errors
[UPDATED 06/27/2012] FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and
Naturalyte GranuFlo (powder) Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in
patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood
pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in
cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
For further information and list of Product Serial numbers please see the Class 1 Recall Notice.
[Posted 05/25/2012]
AUDIENCE: Nephrology, Nursing
ISSUE: FDA is notifying health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate
concentrates when determining the patients dialysate prescription. The FDA received a complaint describing alkali dosing errors that
occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of
alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is
a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac
arrhythmia.
BACKGROUND: Dialysate is a solution prescribed by physicians for use in the treatment of acute and chronic renal failure during the
hemodialysis procedure. The dialysate solution is used in combination with the hemodialysis machine and dialyzer to remove wastes from
the blood.
Dialysate acid concentrate can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to
bicarbonate, potentially contributing to metabolic alkalosis. These substances typically are found in acid concentrate in amounts ranging
from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or
citrate.
RECOMMENDATION: Health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they
prescribe to determine the components that can contribute to the patients overall bicarbonate levels. The levels of acetate, citrate and/or
acetic acid vary by formulation and by manufacturer. Be aware that metabolic alkalosis (pre-足dialysis serum bicarbonate levels > or = to 27
mEq/L) has been associated with a higher risk of death in hemodialysis patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the
FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
Safety
Home Safety MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information
This document was uploaded by the law firms
that sponsor the http://dialysis-lawsuits.org
website, where you can get more information
and a free legal review of your potential
dialysis lawsuit.](https://image.slidesharecdn.com/safetyalertsforhumanmedicalproductsdialysateconcentratesusedinhemodialysissafetycommunication-alkali-130716214317-phpapp01/85/Safety-alerts-for-human-medical-products-dialysate-concentrates-used-in-hemodialysis-safety-communication-alkali-dosing-errors-highlighted-1-320.jpg)
![7/16/13 Safety Alerts for Human Medical Products > Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm 2/2
Download form2 or call 1-足800-足332-足1088 to request a reporting form, then complete and return to the address on the pre-足addressed
form, or submit by fax to 1-足800-足FDA-足0178
[06/27/2012 -足 Recall Notice3 -足 FDA]
[05/25/2012 -足 Safety Communication4 -足 FDA]
Page Last Updated: 06/27/2012
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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4. /MedicalDevices/Safety/AlertsandNotices/ucm305477.htm](https://image.slidesharecdn.com/safetyalertsforhumanmedicalproductsdialysateconcentratesusedinhemodialysissafetycommunication-alkali-130716214317-phpapp01/85/Safety-alerts-for-human-medical-products-dialysate-concentrates-used-in-hemodialysis-safety-communication-alkali-dosing-errors-highlighted-2-320.jpg)
Safety alerts for human medical products dialysate concentrates used in hemodialysis safety communication - alkali dosing errors highlighted
- 1. 7/16/13 Safety Alerts for Human Medical Products > Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm 1/2 Dialysate Concentrates Used in Hemodialysis: Safety Communication -足 Alkali Dosing Errors [UPDATED 06/27/2012] FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death. For further information and list of Product Serial numbers please see the Class 1 Recall Notice. [Posted 05/25/2012] AUDIENCE: Nephrology, Nursing ISSUE: FDA is notifying health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients dialysate prescription. The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. BACKGROUND: Dialysate is a solution prescribed by physicians for use in the treatment of acute and chronic renal failure during the hemodialysis procedure. The dialysate solution is used in combination with the hemodialysis machine and dialyzer to remove wastes from the blood. Dialysate acid concentrate can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis. These substances typically are found in acid concentrate in amounts ranging from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or citrate. RECOMMENDATION: Health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patients overall bicarbonate levels. The levels of acetate, citrate and/or acetic acid vary by formulation and by manufacturer. Be aware that metabolic alkalosis (pre-足dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1 Safety Home Safety MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information This document was uploaded by the law firms that sponsor the http://dialysis-lawsuits.org website, where you can get more information and a free legal review of your potential dialysis lawsuit.
- 2. 7/16/13 Safety Alerts for Human Medical Products > Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm 2/2 Download form2 or call 1-足800-足332-足1088 to request a reporting form, then complete and return to the address on the pre-足addressed form, or submit by fax to 1-足800-足FDA-足0178 [06/27/2012 -足 Recall Notice3 -足 FDA] [05/25/2012 -足 Safety Communication4 -足 FDA] Page Last Updated: 06/27/2012 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-足888-足INFO-足FDA (1-足888-足463-足6332) Email FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: 1. http://www.fda.gov/MedWatch/report.htm 2. /Safety/MedWatch/HowToReport/DownloadForms/default.htm 3. /MedicalDevices/Safety/ListofRecalls/ucm309990.htm 4. /MedicalDevices/Safety/AlertsandNotices/ucm305477.htm